Embolic deflection device

ABSTRACT

There is disclosed a porous emboli deflector for preventing cerebral emboli while maintaining cerebral blood flow during an endovascular or open surgical procedure. The device prevents the entrance of emboli of a size able to cause stroke (such as greater than 100 microns) from entering either the right or left common carotid arteries, and/or the right or left vertebral arteries by deflecting emboli downstream of these vessels. The device can be placed prior to any manipulation of the heart or aorta allowing maximal protection of the brain during the index procedure. The deflector has a low profile within the aorta which allows sheaths, catheters, or wires used in the index procedure to pass. Also disclosed are methods for insertion and removal of the deflector.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/590,230, filed Oct. 1, 2019, which is a continuation of U.S. patentapplication Ser. No. 15/153,552, filed May 12, 2016, now issued as U.S.Pat. No. 10,426,591, which is a continuation of U.S. patent applicationSer. No. 12/685,591, filed Jan. 11, 2010, now issued as U.S. Pat. No.9,339,367, which claims priority under 35 U.S.C. § 119(e) as anonprovisional of U.S. Provisional App. No. 61/143,426 filed on Jan. 9,2009, and also claims priority under 35 U.S.C. § 120 as acontinuation-in-part application of U.S. patent application Ser. No.12/440,839 filed on Mar. 11, 2009, now issued as U.S. Pat. No.9,480,548, which is a 35 U.S.C. § 371 national stage application of PCTApplication No. PCT/US2007/078170 filed on Sep. 11, 2007, which is acontinuation-in-part application of U.S. patent application Ser. No.11/518,865, filed on Sep. 11, 2006, now issued as U.S. Pat. No.8,460,335. Ser. No. 12/685,591 also claims priority as a continuation-inpart application of PCT Application No. PCT/US2010/020530 filed on Jan.8, 2010, which claims priority to the aforementioned U.S. ProvisionalApp. No. 61/143,426 filed on Jan. 9, 2009. All of the aforementionedpriority applications are hereby incorporated by reference in theirentireties.

FIELD OF THE INVENTION

The invention generally relates to systems and method for deflection ofembolic debris, such as during an operative, such as interventional oropen surgical procedures in some embodiments.

BACKGROUND OF THE INVENTION

Endovascular procedures are being used more and more frequently to treatvarious cardiac and vascular surgical problems. Blocked arteries can betreated with angioplasty, endarterectomy, and/or stenting, usingminimally invasive endovascular approaches. Aneurysms can be repaired byendovascular techniques. Another use for endovascular surgery is thetreatment of cardiac valvular disease. Valvuloplasties are already beingdone endovascularly and percutaneous valve replacement is being testedin the United States and devices are already approved for use in Europe.One potential problem which is common to all these endovascularmanipulations is that plaque found in the diseased vessels and valvescan be dislodged and result in embolization. Similarly, a potentialcomplication resulting from endovascular treatment of cardiac valves orthe thoracic aorta is that the dislodged debris can embolize into thecarotid vessels resulting in catastrophic consequences such as stroke oreven death. Any procedure involving the passage of catheters across theaortic arch carries this risk of causing carotid emboli.

Patients requiring cardiac or aortic arch procedures are high riskcandidates for having carotid disease. These procedures simultaneouslyplace both carotid arteries at risk for emboli. The chance of causing astroke by the placement of a protective device into both carotidarteries makes the risk of using these devices prohibitive. The time andskill necessary to selectively cannulate both carotid arteries forfilter placement has also contributed to the decision not to use themdespite the stroke risk of unprotected cardiac and aortic archprocedures.

Only a small number of devices have recently been developed which aredesigned to protect both carotid arteries at the same time. One deviceto date has come to market which protects both carotid arteries fromemboli. Edwards Lifesciences' EMBOL-X™ is a device designed for use inopen heart surgery during cardiopulmonary bypass. The device is afiltering screen inserted directly into the ascending aorta immediatelybeyond the heart, similar to a dryer vent screen. This screen filtersall blood exiting the heart and bypass machine prior to allowing it topass to the downstream circulation. Limitations of this device includeits applicability only to open heart surgery, excluding its use in thevast array of endovascular procedures requiring protection. Adoption ofthe device has been hampered by ease of use, as operators often find itcumbersome. The device could not be adapted to endovascular proceduresas the EMBOL-X™ completely spans the aorta. Thus, wires or catheterscould not pass by it without breaking its protective seal. It has foundlimited adoption, and is chiefly employed for high risk patientsundergoing open heart surgery. NeuroSonix Ltd. has developed theEmBlocker™, an ultrasound based scheme to deflect emboli away from thecerebral circulation during open cardiac procedures. An ultrasound probeis placed through the sternal wound and ultrasonic energy is directed atthe blood flow in the aortic arch with the intent of deflecting emboliaway from the cerebral circulation. Another proposed version for use inendovascular procedures is in the form of an externally applied “collar”around the neck of the patient, which would apply ultrasound through theneck with the hope of deflecting embolic particles away from the carotidcirculation. It is known that the ultrasound beam can be tolerated onlyfor brief periods of time and that it is turned off and on at differentpoints during procedures. Thus, there would be a lack of completeprotection from beginning to end of an open heart procedure orendovascular procedure.

One additional device being developed for aortic embolic protection isthe SagaX AEPD™ which is placed in the aorta through a femoral arteryand secured in position with wire bows pressing against the wall of theaorta and another vessel wall. A key difference and disadvantage of thisdevice is that, when it is positioned to cover the vessels of the aorticarch, one of its bows spans the aorta. Although a catheter from theindex procedure might be able to pass through the open loop of the bowthere is the possibility for entanglement, of dislodging the device, orof pressing against the bow causing damage to the aortic wall. Anotherdifference and disadvantage of this device includes its delivery throughthe as yet unprotected aorta. The device is delivered across the aorticarch, which could cause emboli, and is manipulated into position in thearch with deployment of its bows against vessel walls while the aorta isunprotected. Other differences and disadvantages include possibledifficulty in positioning, difficulty in sealing it in position, andpossible trauma to the vessel walls from the pressure of the bows.

Intravascular filtering devices of the prior art generally share certainadditional disadvantages. For example, captured emboli reduce perfusionthrough the filter. In addition, closing the filter to withdraw theemboli from the body can be difficult depending upon the volume ofentrapped emboli.

Thus, notwithstanding the efforts in the prior art, there remains a needfor an embolic protection device of the type that can permittransluminal or surgical procedures in the vicinity of the heart, whileprotecting the cerebral vasculature.

SUMMARY OF THE INVENTION

Disclosed herein are systems and methods for embolic deflection,including systems for deployment and removal. In one embodiment,disclosed is a method of deflecting emboli flowing within a main vesselfrom entering a side branch vessel. The method includes the steps ofadvancing an emboli deflection device through a first side branch vesseland into the main vessel, and manipulating the deflection device suchthat it covers the opening to a second side branch vessel, wherein thedeflection device permits blood flow from the main vessel into thesecond side branch vessel, but deflects emboli from entering the secondside branch vessel without obstructing the lumen of the main vessel. Thefirst side branch vessel could be, for example the brachiocephalicartery. The second side branch vessel could be, for example, the leftcommon carotid artery. The main vessel could be the aorta. In someembodiments, the emboli deflection device can be advanced through asheath that removably houses the emboli deflection device. The sheathcould be, for example, no larger than 6 French in diameter.

In another embodiment, disclosed is a method of deflecting emboliflowing within a main vessel from entering first and second side branchvessels, including the steps of advancing an emboli deflection devicethrough the first side branch vessel and into the main vessel; andmanipulating the deflection device such that it covers the ostia of eachof the first and second side branch vessels, wherein the deflectiondevice permits blood flow from the main vessel into each of the firstand second side branch vessels, but deflects emboli from entering thefirst and second side branch vessels without obstructing the lumen ofthe main vessel.

In some embodiments, the methods disclosed herein could be performedprior to, such as within 24 hours prior to a procedure such as acoronary angioplasty procedure, a cardiac valve replacement procedure,an aortic repair procedure, a cardioversion procedure, or in a patienthaving a cardiac arrhythmia.

In some embodiments, disclosed herein is a method of deflecting emboliflowing within a main vessel from entering first and second side branchvessels, including the steps of advancing an emboli deflection deviceinto the main vessel; and manipulating the deflection device such thatit covers the ostia of each of the first and second side branch vessels,wherein the deflection device permits blood flow from the main vesselinto each of the first and second side branch vessels, but deflectsemboli from entering the first and second side branch vessels withoutobstructing the lumen of the main vessel.

Also disclosed herein is a method of deploying an embolic deflector,comprising the steps of: providing an elongate, flexible tubular body,having a proximal end, a distal end, and a central lumen; the centrallumen containing a deflector having a first end and a second end;advancing the distal end of the tubular body through a side branchvessel and into a main vessel; and advancing the deflector distallyrelative to the tubular body, such that the first end of the deflectorextends from the tubular body within the main vessel in an upstreamblood flow direction of the main vessel, and the second end of thedeflector extends within the main vessel in a downstream blood flowdirection of the main vessel from the tubular body. In some embodiments,at least one of the first and second ends of the deflector comprisesradiopaque markers thereon. In some embodiments, advancing the distalend of the tubular body through a side branch vessel is accomplishedusing fluoroscopy.

Also disclosed herein is a method of establishing a seal between anembolic deflector and a main vessel wall, comprising the steps of:providing an embolic deflector assembly, having an elongate flexibleshaft and an embolic deflector on a distal end of the shaft, thedeflector movable between an axial orientation and a transverseorientation with respect to the shaft; advancing the deflector through aside branch vessel and into a main vessel while the deflector is in theaxial orientation; converting the deflector to the transverseorientation within the main vessel; and applying traction to the shaftto bring the deflector into sealing engagement with a wall of the mainvessel surrounding the opening to the side branch vessel. In someembodiments, applying traction to the shaft further comprises bringingthe deflector into sealing engagement with a wall of the main vesselsurrounding the openings to at least side two branch vessels. Applyingtraction to the shaft can include manipulating a torque control, in someembodiments.

In another embodiment, disclosed herein is a method of establishing andmaintaining for a desired time, a seal between an embolic deflector anda main vessel wall, comprising the steps of: providing an embolicdeflector assembly, having an elongate flexible shaft and an embolicdeflector on a distal end of the shaft, the deflector movable between anaxial orientation and a transverse orientation with respect to theshaft; advancing the deflector through a side branch vessel and into amain vessel while the deflector is in the axial orientation; convertingthe deflector to the transverse orientation within the main vessel;applying traction to the shaft to bring the deflector into sealingengagement with a wall of the main vessel surrounding the opening to theside branch vessel; and maintaining the traction. In some embodiments,the application of traction is maintained by applying frictional forcesto the elongate flexible shaft, or by actuating a locking mechanismoperably connected to the shaft.

In some embodiments, described herein is a method of removing an embolicdeflection device having an elongate, flexible shaft extending through aside branch vessel and a deflector at the distal end of the shaftpositioned within a main vessel, the deflector comprising a firstportion extending in a first longitudinal direction within the mainvessel and a second portion extending in a second longitudinal directionwithin the main vessel from a patient. The method can be accomplished bydrawing the deflector proximally into the distal end of a tubular bodysuch that the first portion advances towards the second portion; andproximally retracting the deflection device through the side branchvessel and from the patient. In some embodiments, the tubular body is asheath surrounding the elongate flexible shaft. Prior to drawing thedeflector proximally, the elongate flexible shaft and tubular body canbe, in some embodiments, advanced into the lumen of the main vessel.

Also disclosed herein is a temporary emboli diversion device thatincludes an elongate, flexible shaft, having a proximal end and a distalend; and a deflector on the distal end. The deflector can have a lengthextending between a first end and a second end and a width extendingbetween a first side and a second side. The deflector can be convertiblebetween a folded configuration in which both the first end and thesecond end point in the distal direction, and a deployed configurationin which the first and second ends point in lateral directions. In someembodiments, the first end and the second end of the device can includeradiopaque markers thereon.

Also disclosed herein is a temporary emboli diversion device, includingan elongate flexible tubular body, having a proximal end, a distal end,and at least one lumen extending therethrough; and an elongate, flexibleshaft, axially movably extending through the lumen; and a deflectorcarried by the shaft, the deflector movable between a firstconfiguration for positioning within the lumen and a secondconfiguration for deployment; wherein the deflector in the secondconfiguration comprises a length measured transverse to the shaft whichexceeds a width measured perpendicular to the length.

In another embodiment, disclosed is a temporary emboli diversion device,comprising an elongate flexible tubular body, having a proximal end, adistal end, and at least one lumen extending therethrough; an elongate,flexible shaft, axially movably extending through the lumen; and adeflector carried by the shaft, the deflector movable between a firstconfiguration for positioning within the lumen and a secondconfiguration for deployment; the deflector comprising a flexible frameextending around the periphery of the deflector, a membrane attached tothe periphery of the deflector, and a suture loop encircling a portionof the flexible frame in at least one location on the periphery of thedeflector.

Another embodiment of a temporary emboli diversion device can comprisean elongate flexible tubular body, having a proximal end, a distal end,and at least one lumen extending therethrough; an elongate, flexibleshaft, axially movably extending through the lumen; and a deflectorcarried by the shaft, the deflector comprising first and secondtransversely biased lobes, each lobe having a medial end carried by theshaft and a lateral end.

Yet another embodiment of a temporary emboli diversion device cancomprise an elongate, flexible shaft, having a proximal end and a distalend; a deflector carried by the shaft, the deflector having only asingle plane of symmetry; wherein the shaft lies within the plane ofsymmetry.

Still another embodiment of a temporary emboli diversion device includesan elongate, flexible shaft, having a proximal end, a distal end and alongitudinal axis; a first porous lobe attached to the distal end of theshaft, the first porous lobe deflectable between an axial orientationand a lateral orientation; and a second porous lobe attached to thedistal end of the shaft, the second porous lobe deflectable between anaxial orientation and a lateral orientation. In some embodiments, thefirst porous lobe and the second porous lobe comprise pores having asize of no greater than 100 micrometers.

Another embodiment of a temporary emboli diversion device comprises anelongate flexible tubular body, having a proximal end, a distal end, andat least one lumen extending therethrough; an elongate, flexible shaft,axially movably extending through the lumen; a deflector carried by theshaft, the deflector extending transversely with respect to the shaftbetween a first end and a second end; and a first radiopaque markercarried by the first end and a second radiopaque marker carried by thesecond end.

A further embodiment of a temporary emboli diversion device includes anelongate flexible tubular body, having a proximal end, a distal end, andat least one lumen extending therethrough; an elongate, flexible shaft,axially movably extending through the lumen; a deflector carried by theshaft, the deflector extending transversely with respect to the shaftand having a length which exceeds its width; and a torque controlcarried by the shaft.

In another embodiment, disclosed is an embolic deflector comprising anelongate, flexible shaft, having a proximal end and a distal end; and adeflector, carried on the distal end of the shaft; wherein the deflectoris curved in at least two axes such that it lacks radial symmetry withrespect to a longitudinal axis of the shaft, and a peripheral edge ofthe deflector has a three dimensional configuration such that itconforms approximately to the interior surface of a non-sphericalgeometry of rotation, such as a cylindrical geometry of rotation in someembodiments, when the deflector is positioned in a main vessel and whenthe shaft extends through a branch vessel under traction.

In another embodiment, disclosed is a method of protecting the cerebralcirculation from embolic debris, comprising the steps of: advancing adeflector into the aorta in the vicinity of the ostium to the leftcommon carotid artery while the deflector is in a first, reduced profileconfiguration; deploying the deflector in the aorta, into a secondconfiguration which is concave in the direction of the ostium; andtransforming the deflector into a third configuration, which is concavetowards a central axis of the aorta.

In another embodiment, disclosed herein is a method of reducing the riskof emboli entering the cerebral circulation as a consequence of an indexprocedure in the heart. The method includes the steps of introducing anelongate, flexible shaft into the vasculature at a point other than afemoral artery, the shaft carrying a deflector thereon; positioning thedeflector in the aorta such that it spans the ostium of at least thebrachiocephalic and left common carotid arteries; introducing an indexprocedure catheter into the femoral artery; advancing the indexprocedure catheter across the thoracic aorta and to a treatment site inthe heart; conducting the index procedure in the heart; removing theindex procedure catheter from the patient; and removing the deflectorfrom the patient. In some embodiments, the index procedure could be atranscatheter aortic valve implantation, a balloon aortic or mitralvalvuloplasty, a mitral or aortic valve replacement, a heart valverepair, or a coronary angioplasty. In some embodiments, the deflector isintroduced into the vasculature via, for example, the ulnar, radial,brachial, axillary, subclavian, or brachiocephalic arteries, or into theaorta. In some embodiments, the deflector additionally spans the ostiumof the left subclavian artery. The deflector could be introduced througha delivery catheter having a size of no greater than about 6 French. Insome embodiments, the deflector comprises an atraumatic surface forcontacting the wall of the aorta. In some embodiments, the removing thedeflector step is accomplished no sooner than 1, 2, 3, 4, 5, 10, 15, 20,30, 40, 50, 60 minutes, or more following completion of the indexprocedure.

Also disclosed herein is a method of reducing the risk of embolientering the cerebral circulation as a consequence of an index procedurein the heart, or in another vessel, such as the aorta. The steps includeintroducing an elongate, flexible shaft into the aorta via thebrachiocephalic artery, the shaft carrying a deflector thereon;positioning the deflector in the aorta such that it spans the ostium ofat least the brachiocephalic and left common carotid arteries, and theleft subclavian artery in some embodiments; conducting an indexprocedure on the heart; and removing the deflector from the patient. Theindex procedure could be conducted, in some cases, via open surgicalaccess, transapical access, or thoracotomy access to a site on theheart.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will now be explained and other advantages and featureswill appear with reference to the accompanying schematic drawingswherein:

FIG. 1 depicts brachial artery insertion of an embolic deflector,according to one embodiment of the invention.

FIG. 2 depicts femoral artery insertion of an embolic deflector,according to one embodiment of the invention.

FIGS. 3A-E depict a method of deployment of an embolic deflector throughthe patient's right arm, thus allowing the deflector to be pulled backagainst the aortic wall to deflect emboli away from the cerebralvasculature, according to one embodiment of the invention.

FIGS. 4A-F depict an alternative method of deployment of an embolicdeflector through the femoral artery wherein the deflector is pushedagainst the aortic wall over the brachiocephalic and left common carotidostia.

FIG. 4G illustrates an embodiment where an embolic deflector is used incombination with a filter spanning the aortic lumen and placeddownstream of the left subclavian artery but upstream of the renalarteries.

FIG. 5 illustrates a perspective view of one embodiment of an embolicdeflector.

FIGS. 6A-B illustrate perspective views of a frame of an embolicdeflector, according to one embodiment of the invention.

FIG. 6C is a longitudinal cross-sectional view of the embolic deflectorof FIG. 6A, through line 6C-6C.

FIG. 6D is a transverse cross-sectional view of the embolic deflector ofFIG. 6A, through line 6D-6D.

FIG. 7 illustrates a schematic view of a membrane portion of an embolicdeflector, according to one embodiment of the invention.

FIG. 8 illustrates one embodiment of a partial cut-away view of ashaft-frame connector for an embolic deflector.

FIGS. 8A-8C illustrate various views of the deflector frame illustratingthe position of the control line including looped ends, according to oneembodiment of the invention.

FIG. 9 illustrates one embodiment of a torque control for an embolicdeflector.

FIG. 10 illustrates components of one embodiment of an embolic deflectordeployment kit.

FIGS. 11-13 depict a deployment sequence for a multi-lobed embolicdeflector, according to some embodiments of the invention.

FIG. 13A depicts an embolic deflector sized and configured to cover theostia of three side branch vessels, including the brachiocephalic, leftcommon carotid, and left subclavian arteries.

FIGS. 14A-K and 15A-15L depict various embodiments of embolic deflectorsin plan view (14A-G), phantom plan view (14H-K) and side view (15A-L).

FIGS. 16A-D depict various embodiments of a locking mechanism between anembolic deflector shaft and an introducer sheath.

FIGS. 17A-D depict various views of another embodiment of an embolicdeflector comprising a coil support which expands and flattens uponemergence from the lumen of a tubular containing structure.

FIGS. 18A-C depict other embodiments of an embolic deflector comprisinga helical (18A), spherical (18B), or onion-shaped (18C) mesh thatflattens into a disc shape upon emergence from the lumen of a tubularcontaining structure.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Disclosed herein are embolic protection systems that includes adeflector, along with associated deployment and removal systems, thatcan advantageously prevent emboli above a predetermined threshold sizefrom entering the cerebral vasculature that may be dislodged, such asduring an index procedure, such as an operative procedure. As such,potentially life-threatening transient ischemic attacks or embolicstrokes can be prevented. Conventional embolic filters are primarilyconfigured to capture, retain and retrieve embolic material. Incontrast, deflectors as disclosed herein are configured to deflect orotherwise divert embolic material to a location downstream (relative tothe direction of blood flow in the vessel in which the deflector isdeployed) of the deployed location of the deflector to a less criticalregion of the body rather than the brain and other tissues perfused bythe carotid and vertebral arteries. Once downstream, the emboli can beacted upon by physiologic anticoagulation mechanisms and/or externallyadministered anticoagulants. When in use, the emboli need notnecessarily physically come into contact the embolic deflection devicefor the device to be effective, so long as the emboli are prevented fromtravelling through the deflector and are instead diverted downstream asnoted above. In some embodiments, the deflector can be deployed in theaortic arch over the ostia of the brachiocephalic and the left commoncarotid arteries. In some embodiments, the deflector can be deployed inthe aortic arch over the ostia of the brachiocephalic, left commoncarotid, and the left subclavian arteries. The right common carotidartery and the right subclavian artery normally branch off thebrachiocephalic artery. The right vertebral artery normally branches offthe right subclavian artery, while the left vertebral artery normallybranches off the left subclavian artery. While the deflector isconfigured to deflect emboli greater than a pre-determined size, such as100 microns for example, into the descending aorta, the deflector isalso preferably configured to be sufficiently porous to allow adequateblood flow through the ostia of the vessels in which the deflector maycontact, such as the brachiocephalic, left common carotid, and/or leftsubclavian arteries, so as to sufficiently maintain perfusion to thebrain and other vital structures.

The method advantageously allows for deflection of emboli flowing withina main vessel, such as the aorta, from entering a side branch vessel,such as the brachiocephalic artery, left common carotid artery, and/orleft subclavian artery while allowing deflection of the emboli furtherdownstream in the main vessel (e.g., the aorta) perfusing less criticalbody organs and other structures, and allowing for lysis of the embolivia physiologic and/or pharmacologic declotting mechanisms. A sidebranch vessel as defined herein is a non-terminal branch vessel off amain vessel, such that the main vessel continues proximally and distallybeyond the ostia of the side branch vessels. For example, thebrachiocephalic artery, left common carotid artery, and left subclavianarteries are side branch vessels of the aorta, which continues distallytoward the abdomen past the ostia of the aforementioned side branchvessels. This is in contrast to main vessels that can split (e.g.,bifurcate) into terminal branch vessels such that the main vessel nolonger exists distal to the ostia of the terminal branch vessels. Oneexample of a main vessel that splits into terminal branch vessels is theabdominal aorta, which terminates distally subsequent to its bifurcationinto the common iliac arteries.

In some embodiments, the deflector can be placed in a first axial,collapsed orientation through a first insertion site, such as an arteryof an upper extremity that is distinct from a second insertion site,such as a femoral or contralateral upper extremity, for catheters andother devices used for a primary procedure. In some embodiments, theembolic deflector can be deployed with no greater than about a 6 Frenchsheath, and can be readily placed using standard Seldinger technique.The device can be collapsed into its reduced crossing profileorientation through a loader, back loaded past the hemostasis valve of asheath, and then advanced through the sheath into a first branch vessel,such as the brachiocephalic artery, and then into a main vessel, such asthe aorta. Within the aorta, the deflector is expanded into an expandedtransverse orientation once removed from the sheath, and is positionedacross the ostia of one or more branch vessels to deflect embolidownstream (with respect to the direction of blood flow in the aorta)into the descending aorta.

In the expanded configuration, the deflector generally has a major axiswith a length that is greater than the length along a transverse, orminor axis. As deployed within the vessel, the major axis is generallyaligned in the direction of blood flow, such that a first end of thedeflector residing on the major axis points in an upstream direction anda second, opposing end of the deflector also residing on the major axispoints in a downstream blood flow direction.

A first end of the deflector can thus be aligned or permitted toself-align and can be secured in position extending upstream in theaorta covering, for example, the ostia of a branch vessel, such as theinnominate artery. The deflector can also be configured tosimultaneously have a second end extending downstream in the aorta tocover the ostia of a second branch vessel (e.g., the left common carotidartery).

The embolic defector is able to be placed before the index procedure isbegun and can remain in place, providing embolic deflection, until theprocedure is completed, or for a shorter or longer period of time asclinically indicated. In some embodiments, the deflector has a very lowprofile in the aorta so that wires, catheters, and sheaths can pass byit without interference. In some embodiments, the deflector isconfigured to deflect emboli greater than, for example, 100 microns insize away from the carotid arteries thus protecting the patient frompotentially devastating neurological consequences of these emboli. Thedeflector can be designed so that one size fits all, or may be providedin a series of graduated sizes.

In some embodiments, a method of reducing the risk of emboli enteringthe cerebral circulation as a consequence of an index procedure in theheart or another blood vessel, such as the aorta, involves the followingsteps. First, an elongate, flexible shaft is inserted into thevasculature at a point other than a femoral artery, or in someembodiments a contralateral femoral artery from that of the insertionpoint for the index procedure. A deflector is then positioned in theaorta such that it spans the ostium of one, two, or more of thebrachiocephalic, left common carotid, and left subclavian arteries. Anindex procedure catheter is then introduced into a femoral artery. Theindex procedure catheter is then advanced across the thoracic aorta to atreatment site in the heart or a blood vessel. The index procedure isthen performed. Some non-limiting examples of index procedures includevalve replacement procedures, including aortic and mitral valvereplacement, including transcatheter aortic or mitral valveimplantation, aortic or mitral valvuloplasty, including balloonvalvuloplasty, heart valve repair, coronary angioplasty, or. coronaryartery bypass grafting. Following completion of the index procedure, theindex procedure catheter is removed from the patient. The deflector isthen removed from the patient. In another embodiment, the methodincludes introducing an elongate, flexible shaft into the aorta, such asvia the brachiocephalic artery, the shaft carrying a deflector thereon.The deflector is then positioned in the aorta such that it spans theostium of one, two, or more of the brachiocephalic, left common carotid,and left subclavian arteries. An index procedure is then performed onthe heart or other vessel, such as the aorta. The deflector can then beremoved from the patient. The index procedure could be performed viaopen surgical access, a less invasive thoracoscopic approach,transapically, percutaneously, or even noninvasively (e.g., an externalDC cardioversion) in some embodiments.

One embodiment of a method of using an embolic deflector to reduce therisk of emboli from entering the circulation during a Balloon AorticValvuloplasty (BAV) procedure will now be described. Wire access isgained through any appropriate access, such as the right radial orbrachial artery and advanced to the ostium of the brachiocephalicartery. A 6 French Sheath with a dilator is then inserted over the wire.The sheath tip is positioned at the ostium of the brachiocephalicartery. An embolic deflector is inserted into the sheath and deployed inthe aorta. The device positioning is confirmed with fluoroscopicimaging. A BAV catheter is inserted via the femoral artery. A BalloonAortic Valvuloplasty catheter is advanced into the descending aorta,around the aortic arch passing by the deflector. The BAV catheter isthen positioned across the aortic valve. The balloon is inflated anddeflated against the stenotic and calcified aortic valve. The BAVcatheter is then removed, passing by the embolic deflector during theretrieval process, through the femoral artery access site. The embolicdeflector and sheath are removed from the radial or brachial artery.

One embodiment of a method of using an embolic deflector to reduce therisk of emboli from entering the circulation during a TranscatheterAortic Valve Implantation (TAVI) will now be described. Wire access isgained through the right radial or brachial artery and advanced to theostium of the brachiocephalic artery. A 6 French Sheath with a dilatoris then inserted over the wire. The sheath tip is positioned at theostium of the brachiocephalic artery. A deflector is inserted into thesheath and deployed in the aorta. The device positioning is confirmedwith fluoroscopic imaging. Multiple wires and catheters are then used toassess the aortic valve and arch anatomy and to dilate the aortic valveprior to the deployment of the transcatheter aortic valve. These devicesare inserted via the femoral artery and pass the deflector. Thetranscatheter aortic valve is then inserted via in a delivery system orcatheter which is inserted via the femoral artery. A transapical ortrans-septal approach could be employed in some embodiments. The TAVIcatheter is advanced into the descending aorta, around the aortic archpassing by the deflector. The valve is then positioned and deployed inthe native aortic valve. The TAVI catheter is then removed, passing bythe deflector device during retrieval through the femoral access site.Once the TAVI catheter is removed, the deflector device and sheath areremoved from the radial or brachial artery. Further details ofreplacement valves and methods of valve implantation that can be usedwith the deflectors described herein can be found, for example, in U.S.Pat. No. 7,618,446 to Andersen et al., U.S. Pub. No. 2008/0004688 toSpenser et al., U.S. Pat. Pub. No. 2007/0043435 to Seguin et al., U.S.Pat. Pub. No. 2008/0140189 to Nguyen et al., and U.S. Pat. Pub. No.2008/0051807 to St. Goar et al., U.S. Pat. Pub. No. 2009/0062908 toBonhoeffer et al., all of which are hereby incorporated by reference intheir entireties.

Deployment of a deflector as described herein can be advantageous for avariety of applications. The applications may include use during a widerange of operative procedures, including but not limited to opencardiothoracic, mediastinoscopy, transapical, or percutaneousprocedures. For example, the embolic deflector could be deployed priorto an angioplasty procedure, such as a balloon angioplasty or rotationalatherectomy involving one, two, or more coronary arteries. The deflectorcould also be deployed prior to a heart valve procedure, such as anopen, transapical, or percutaneous mitral or aortic valve replacement orrepair or valvuloplasty procedure. In some embodiments, the deflectorcould be deployed prior to repair of an aortic aneurysm and/ordissection. In still other embodiments, the deflector could be deployedprior to electrical or pharmacologic cardioversion of an arrhythmiawhere there may be an increased potential risk of embolization followingreturn to normal sinus rhythm post-cardioversion, such as in atrialfibrillation, atrial flutter, multifocal atrial tachycardia, ventriculartachycardia, ventricular fibrillation, or torsades de pointes forexample. In some embodiments, the embolic deflector could be utilized inany index procedure involving the passage of catheters crossing theatrial septum, including cardiac ablation procedures of ectopic atrialor ventricular foci, leading to arrhythmias. Other examples of indexprocedures could include repair of shunt defects, including atrialseptal defects, ventricular septal defects, patent foramen ovale, andTetralogy of Fallot.

In some embodiments, the deflector is deployed within a patient no morethan about 48 hours, 36 hours, 24 hours, 12 hours, 8 hours, 6 hours, 4hours, 3 hours, 2 hours, 1 hour, or less prior to the index procedure.In some embodiments, the deflector is removed from a patient no soonerthan 1, 2, 3, 4, 5, 10, 15, 20, 30, 40, 50, 60 minutes, or morefollowing completion of the index procedure.

In some embodiments, deflector embodiments as disclosed herein could bedeployed into the venous circulation, such as in the superior orinferior vena cava, for the prevention of pulmonary embolism.

In some embodiments, the deflector can be deployed for short-term orlong-term protection against emboli even in when an operative proceduremay not be contemplated, such as, for example, with a hypercoagulablestate, cancer, atrial fibrillation, endocarditis, rheumatic heartdisease, sepsis, including fungal sepsis, patent foramen ovale, atrialseptal defect, ventricular septal defect, other arteriovenous shunt, orpatients already having an implanted prosthetic device prone to emboliformation, such as having a prosthetic heart, left ventricular assistdevice, replacement mitral or aortic valve, and the like. For example, apatient may be on anticoagulant therapy for one, two, or more of theaforementioned conditions, but need to temporarily discontinue themedication for an upcoming procedure, or the medication may betemporarily contraindicated because of an acute bleed such as agastrointestinal bleed, and thus be at risk for embolic stroke. Adeflector can thus be deployed for the period of time in which thepatient has discontinued their anticoagulation therapy, which may bemore than about 12, 18, 24, 36, 48, 72 hours, or more. In otherembodiments, the deflector can be configured for more long-termimplantation, such as for at least about 1, 4, 6 or 8 weeks, or evenmore. However, in other more short-term applications, the deflector isdeployed within the body for no more than about 24, 18, 12, 6, 4, 3, 2,1 hour, or even less.

In some embodiments, the device may also be deployed into a position inwhich one edge is inside the brachiocephalic artery, covering the ostiumof the right common carotid, and in which the opposite edge extends intothe aortic lumen and covers the ostium of the left common carotidartery, leaving the brachiocephalic ostium substantially unobstructed bythe deflector.

Referring now to FIG. 1, in one embodiment, a deflector 100 can bedelivered via percutaneous or cut-down insertion into the right brachialartery 20, advanced to the right subclavian artery 18, and then isguided into the aortic arch 12. The deflector 100 can then be deployedand then pulled back under traction into position to cover the ostia ofthe brachiocephalic artery 16 (which may also be referred to herein asthe innominate artery or the brachiocephalic trunk) and left commoncarotid artery 24. The deflector 100 deflects emboli duringcardiovascular procedures, allowing the flow of blood through deflector100 and into the cerebral circulation (carotid arteries) sufficient tomaintain perfusion to the brain and other vital structures, while at thesame time not permitting the passage of emboli into the cerebrovascularcirculation of a size which could cause stroke. Also illustrated in FIG.1 for anatomical reference is the descending aorta 14, right commoncarotid artery 22, aorta 10, and left subclavian artery 26.

Referring now to FIG. 2, in one embodiment, the deflector 100 isdelivered via percutaneous or cut-down insertion into a femoral artery(such as the left femoral artery 30) and is guided upstream from thedescending aorta 14 into the aortic arch 12. After catheterization ofthe brachiocephalic artery 16, the device 100 is passed over a guidewireor through a lumen of a deployment catheter and brought into positionand maintained under distal pressure covering the ostia of thebrachiocephalic artery 16 and or the left common carotid 24 arteries,and additionally the left subclavian artery 26 (not shown) in someembodiments.

Referring now to FIGS. 3A-E, percutaneous access to the circulation viaan upper extremity (through any appropriate artery, such as the radial,ulnar, brachial, axillary, or subclavian artery) is performed and aguidewire is advanced into the aortic arch after exiting the innominateartery.

A delivery catheter 102 is thereafter advanced over the wire to positiona distal end of the delivery catheter in or in the vicinity of theaorta. Additional details of the delivery catheter and other mechanicalcomponents will be provided below. In general, the delivery cathetercomprises at least one central lumen for receiving the deflectortherethrough. The crossing profile of the system may be minimized byproviding a delivery catheter 102 which comprises only a single lumentube, such as a single lumen extrusion. This delivery tube may beadvanced over the guidewire into position within the aorta. Theguidewire is then proximally retracted and removed from the deliverycatheter, leaving the central lumen available to receive the deflectiondevice therethrough.

In the illustrated embodiment, the delivery catheter 102 is placed overthe wire and guided into the aortic arch. The guidewire is retracted andthe deflection device is axially distally advanced through the centrallumen thereby exposing the device 100 to the aortic arch 12 bloodstream(FIG. 3A). The device 100 is then expanded in the aortic arch 12 (FIG.3B). The device 100 is pulled back into position, covering the ostia 17of the innominate artery 16 as well as the ostia 25 of the left commoncarotid artery 24 (FIG. 3C). The device 100 allows the passage of bloodthrough to the carotid arteries 22, 24 while still deflecting emboligenerated by aortic or cardiac surgery or other procedure away fromthese arteries, and downstream into the descending aorta. At thecompletion of the debris-producing concomitant procedure or followingelapse of any other desired period of time, the device 100 is closed andwithdrawn into the central lumen of deployment catheter 102 (FIG. 3E) tocompletely encapsulate it prior to removal from the arm access artery(not shown).

Referring now to FIGS. 4A-F, in another embodiment, the innominateartery 16 is catheterized with a wire 104 placed via femoral access.Over the wire, the deflector 100 deployment system is guided intoposition in the aortic arch 12, where the deflector is deployed, forexample, by retraction of the sheath 102 (FIG. 4A). The device 100 isthen pushed, over the wire 104 in the innominate artery 16, intoposition securely covering the ostia 17 of the innominate artery 16 andostia 25 of the left common carotid artery 24 (FIG. 4B). As discussedabove, the device 100 allows the passage of blood through to the carotidarteries 22, 24, but deflects emboli generated by aortic or cardiacsurgery away from these arteries. At the completion of thedebris-producing concomitant procedure or other period of time elapsed,the device 100 is closed by inverting the optional covering cap 101(FIG. 4C), shown here by means of drawstrings. The device 100 is thencollapsed (FIG. 4D) and withdrawn into a covering sheath 102 (FIG. 4E)to completely encapsulate it prior to removal from the leg accessartery. Any trapped debris is enfolded within the closed cap 101, safelyand securely within the covering sheath 102. The wire 104 and device 100are then withdrawn from the femoral access.

In still other embodiments in which the ostia of three side branchvessels, such as the brachiocephalic artery, left common carotid artery,and left subclavian arteries are all to be covered by a deflector, analternative deployment method would be through insertion of the vesselinto the left upper extremity, such as the left radial, ulnar, brachial,axillary, or subclavian arteries. The deflector could be advanced intothe aortic arch from the left subclavian artery, expanded, and thentraction could be placed to create a seal with the aortic wall to coverthe ostia of the three side branch vessels as discussed above.

Since deployment of the embolic deflection device via a femoral arteryaccess can require placement of the deployment catheter across thethoracic aorta, this approach may be desirable for use in conjunctionwith heart procedures accomplished surgically, transapically, or viaalternate access pathways that do not involve traversing the thoracicaorta with the primary procedure device.

In some embodiments, the device could also be used with open orthoracoscopic cardiac or aortic procedures. In these cases, the devicecould be placed in either manner described above, or via direct punctureor via guidance under imaging, such as fluoroscopy, into the aorta,brachiocephalic artery, right or left subclavian artery, or othersuitable vessel if the arch were exposed. If it were placed directly, itwould be pushed into place as with the femoral approach. Alternatively,any appropriate surgical, percutaneous, or endoscopic procedure may beemployed to place the device.

During deployment as described above, in an embodiment in which thedeflector is preloaded into the sheath 102 prior to advance to thetreatment site, the deflector 100 may be locked in position relative tothe sheath 102 using a rotating valve, torque control, or similarmechanism. The sheath 102 can then be held in position at the skinusing, for example, a hemostat, clip, tape, Tegaderm™ or other adhesivefilm. The deflector 100 remains tethered by the shaft, and tensionedagainst the vessel wall by application of tractional force external tothe patient. In some embodiments, a deployment system includes anintermediate biasing structure that reversibly locks the deflector 100in position when a predetermined amount of tractional force is appliedby a physician to place the deflector 100 in sealing contact against thevessel wall. The intermediate biasing structure could be, for example, aspring having a predetermined spring bias. Such an intermediate biasingstructure could be advantageous in eliminating potential variabilityfrom physician in the amount of tractional force applied, to create anoptimal seal as well as a safety feature to avoid damage to the intimalvessel wall or other structures. The deflector 100 and/or shaft may beelastic to accommodate movement or shifting during use, so as tomaintain protection of the vasculature. The deflector 100 is preferablytethered to permit repositioning or removal at any time.

In some embodiments, mechanism of deflector expansion from the collapseddelivery configuration could include opening an umbrella (with orwithout struts), overlapping of opening lobes (blooming), opening ofoverlapping elements as in an iris, memory-restoration of a preformedshape, mushrooming, expansion of pores or cells, and release ofsupporting elements that form the peripheral shape with porous materialstretched between.

The deflector may be transformed from the collapsed configuration to theopen configuration using either passive or active mechanisms. In apassive expansion configuration, for example, the frame for thedeflector is biased into the direction of the open configuration. Thedeflector is constrained within the delivery catheter 102, until thedelivery catheter 102 is withdrawn proximally relative to the deflector,to expose the deflector within the aorta. At that point, the deflectorexpands radially outwardly under an internal bias. In oneimplementation, the sheath is held in a fixed axial position and theshaft is advanced distally therethrough to advance the deflector out ofthe distal end of the sheath. The opening bias may be provided by any ofa variety of structures and materials, such as through the use ofNitinol, Elgiloy® or certain stainless steel alloys, as is known in theart. Alternatively, active opening mechanisms may include the use of oneor more pull or push wires, or a rotational element, which can beactively manipulated to convert the deflector from the reduced profileto the enlarged profile.

In some embodiments, the method can be modified to account for patientanatomical abnormalities, such as abnormalities of the aortic arch. Insome embodiments, the deflector 100 could cover the ostia of a singlevessel, or a first deflector 100 could be sized to cover the ostia of afirst vessel, and a second deflector 100 could be sized to cover theostia of a second vessel. For example, some patients may have an aorticarch side branch vessel abnormality where the right common carotidartery and the left common carotid artery are both direct side branchvessels off the aortic arch, or the right and left common carotid arterybifurcate off a single side branch vessel off the aortic arch. Thepatient's vascular anatomy can be first determined, such as byangiography, CT angiography, MRI, doppler ultrasound, or other method.One, two, or more deflecting devices could be positioned at or near theostia of one, two, three, or more side branch vessels (potentially morein patients with a double aortic arch) such that the end result is thatall emboli larger than a predetermined size are prevented from reachingthe brain including brainstem, eyes, or other critical structuresperfused by the carotid and/or vertebral arteries.

In addition to deflectors 100 as described herein, conventional embolicprotection devices including arterial and venous filters can also besized and configured to be placed in a main vessel over the ostia of atleast a first, second, or more side branch vessels and used with themethods disclosed herein, such as, for example, the brachiocephalicartery and the left common carotid artery as described above. In someembodiments, an embolic protection device sized and configured to spanthe aorta, such as the descending aorta, can be placed downstream of thedeflector in the aortic arch to capture emboli before reaching the ostiaof the renal arteries. FIG. 4G schematically illustrates a deployeddeflector 100 that can cover the ostia of the brachiocephalic 16, leftcommon carotid 24, and also the left subclavian artery 26. An adjunctembolic filter 99 can be placed in the aorta 10 downstream of the ostiaof the left subclavian artery 26 but upstream of the ostia of the left 9and right 8 renal arteries in order to trap emboli prior to potentialembolization into the renal arteries 8, 9. In some embodiments, theembolic filter 99 could be a stand-alone filter as shown temporarilypositioned and secured in the aorta via any desired mechanism, such aswith anchors such as barbs, attached to a control line extending fromthe left or right femoral arteries or a right or left upper extremityartery, or tethered to the deflector 100 in some embodiments. Theembolic filter 99 could then be removed from body following completionof the index procedure. Some examples of embolic protection devicesincluding filters that can be used or modified for use with the methodsdescribed herein, as well as deployment and removal methods for thosefilters can be found, for example, in U.S. Pat. No. 4,619,246 toMolgaard-Nielsen et al., U.S. Pat. No. 5,634,942 to Chevillon et al.,U.S. Pat. No. 5,911,734 to Tsugita et al., U.S. Pat. No. 6,152,946 toBroome et al., U.S. Pat. No. 6,251,122 to Tsukernik, U.S. Pat. No.6,346,116 to Brooks et al., U.S. Pat. No. 6,361,545 to Macoviak et al.,U.S. Pat. No. 6,375,670 to Greenhalgh et al., and U.S. Pat. No.6,447,530 to Ostrovsky et al., all of which are hereby incorporated byreference in their entireties.

In some embodiments, an embolic deflector 100 includes the followingcomponents, as illustrated in FIG. 5. The deflector 100 can include aflexible frame 106 having a size sufficient to surround or support adeflection membrane across the ostia of both the brachiocephalic andleft common carotid arteries while the deflector 100 is positioned inthe aorta, specifically within the aortic arch region of the aorta.However, in other embodiments, the deflector 100 could be sized to coverthe ostia of a single vessel, or a first deflector 100 could be sized tocover the ostia of a first vessel, and a second deflector 100 could besized to cover the ostia of a second vessel. The frame 106 can beflexible, and take a wide variety of shapes to allow continuous orsubstantially continuous contact with the sidewall of the aortic archlumen. The frame 106 surrounds or supports a membrane 108 which can beporous or include apertures such that the permeability of the membrane108 allows the flow of blood into the cerebral circulation, while stilldeflecting and/or trapping emboli of a size which could cause a stroke.

The frame 106 is operably connected to an elongate, flexible shaft 300to permit axial reciprocal movement of the deflector. In the illustratedembodiment, the frame 106 is connected to flexible shaft 300 by firstand second struts 110. First and second struts 110 curve or inclineradially outwardly in the distal direction, to assist in expanding thedeflector 100 for deployment or alternatively contracting the deflector100 for removal as it is drawn proximally into the deployment catheter102. Three or four or more struts may be alternatively used. In someembodiments as illustrated, the deflector has only a single plane ofsymmetry, and the shaft 300 lies within that plane of symmetry (e.g.,the plane of symmetry runs coaxial with the shaft 300 and extends acrossthe minor (transverse) axis of the deflector).

The deflector 100 can also include one, two, or more control lines 42which can assist in retrieving the deflector 100. The control line 42,which can be a loop of suture or other suitable material, could extendaround the periphery of the membrane and be trapped by the membraneheat-bond or otherwise be secured to or near the periphery of themembrane. In some embodiments, one, two, or more suture loops passthrough section(s) of membrane. Control line 42 assists in collapsingthe device into the sheath 102 (not shown) during retrieval, byresisting the membrane from sliding along the frame 106. Control line 42could pass over either the proximal or distal side of the frame.Alternatively, the membrane can be secured directly to the frame suchthat it does not slide on the frame upon retraction into the sheath, andthe control lines can be omitted. The integrity of the bond will dependin part upon the materials of the frame and membrane. Depending uponthose materials, any of a variety of bonding techniques may be utilized,such as adhesives, thermal bonding, or application of bonding or tielayers such as a polypropylene or FEP layer bonded to the frame which isheat bondable to itself and/or to the material of the membrane. Thedeflector 100 can also include one, two, or more radiopaque markers 170that may be present on the lateral ends of the frame 106 and/or on theshaft 300 as shown, or in other clinically desirable locations. Furtherdetails and illustrations of various components of a deflector 100, insome embodiments, will be disclosed below.

FIG. 6A illustrates a frame 106 of a deflector 100, according to oneembodiment of the invention. The frame can be made of any appropriatebiocompatible material, such as Nitinol, Elgiloy®, Phynox®, MP35N alloy,stainless steel, titanium, or a shape memory polymer that could beeither nonbiodegradable or biodegradable, in some embodiments. Someexamples of suitable polymers include poly(alpha-hydroxy acid) such aspoly-L-lactide (PLLA); poly-D-lactide (PDLA), polyglycolide (PGA),polydioxanone, polycaprolactone, polygluconate, polylacticacid-polyethylene oxide copolymers, modified cellulose, collagen,poly(hydroxybutyrate), polyanhydride, polyphosphoester,poly(amino-acids), or related copolymer materials.

The frame 106 can be configured such that it is transformed from afirst, low-profile reduced configuration during delivery to a second,expanded configuration while in use, and if necessary, back to the firstlow-profile reduced configuration for later removal. In someembodiments, as depicted in FIG. 6A, at least a substantial portion ofthe frame 106 is constructed from a single laser-cut piece of material.The frame 106 can also be assembled from two or more wires that areformed and welded or otherwise bonded together. In the illustratedembodiment, the frame includes a peripheral strut which is configuredinto two closed lobes bilaterally symmetrically positioned relative tothe shaft 300. Additional struts may be included such as in a zig-zagconfiguration within each lobe.

While the frame 106 can be substantially flat from a first lateral endto a second lateral end, in some embodiments, the frame 106 is formed sothat it is first biased into a proximally concave shape when in anunconstrained expansion, having a compound curvature to form a fittingseal against the aortic wall when it is deployed. In other words, themidpoint of the frame 106 where the shaft 300 is attached can belongitudinally offset along the axis of the shaft from the lateral endsof the frame 106, such as by at least 2, 4, 6, 8, 10, 12, 15 mm, ormore, or between about 7-11 mm in some embodiments. The frame 106 canalternatively be formed by injection molding, cold forming, casting, orany other suitable method, or combination of methods, or the frame maybe formed to assume the desired configuration upon inflation, heating,cooling, or exposure to body fluids.

The frame 106 can be defined as having a major axis (maximum length) X1between a first lateral end and a second lateral end, and a minor axis(maximum width) X2 between a first side and a second side of the framewhen laid flat and fully expanded, as well as a height X3 as illustratedin FIG. 6A. When laid flat, the frame can be sized to ensure coverage ofboth the brachiocephalic and left common carotid artery over a widerange of anatomies.

In some embodiments, the frame 106 is bilaterally symmetric and radiallyasymmetric, and has a major axis distance X1 that is at least about100%, 110%, 120%, 130%, 140%, 150%, 175%, 200%, 225%, 250%, 275%, 300%,325%, 350%, 400% or more relative to the minor axis distance X2.However, in other embodiments, the frame 106 may be radially symmetriclike an umbrella, where the distances X1 and X2 are the same orsubstantially the same.

In some embodiments, the frame 106 has a length X1 of from about 40 mmto about 80 mm, such as from about 50 mm to about 70 mm, such as betweenabout 56 mm to about 60 mm. The frame 106 can have a width X2 of fromabout 20 mm to about 30 mm, or from about 23 mm to about 27 mm in someembodiments. The frame 106 has a height X3 of from about 7 mm to about11 mm, such as from about 8.5 to about 9.5 mm in some embodiments.

Still referring to FIG. 6A, the frame 106 can be defined by at least afirst lobe 132 and a second lobe 134 biased in opposing radially outwarddirections, and intersected by struts 110, 120 meeting and becominglongitudinally offset from the frame 106 at junction 130. Struts 110,120 and can be, in some embodiments, follow the minor axis X2 of theframe near the midpoint of the length along major axis X1 of the frame106. The frame 106 can be attached to the shaft (not shown) via, forexample, an interlocking feature cut into each of the central struts110, 120 near junction 130. Complementary mating mechanical engagementstructures can ensure sufficient strength for deployment, manipulationand retrieval of the device. However, heat welding, bonding, adhesives,or other attachments between the frame 106 and the shaft can also beutilized. In some embodiments, a segment of hypodermic tubing can beplaced, such as crimped and/or bonded in place over the junction 130 foradded stability.

As illustrated in FIG. 6A, first lobe 132 has a lateral end 142 and amedial end 148, while second lobe 134 also has a lateral end 144 and amedial end 146. Lobes 132, 134 also have a first side 151 and a secondside 153, the distance between sides 151, 153 of which defines the widthX2 of the frame 106. Lobes 132, 134 are movable between an axialorientation prior to delivery (best illustrated in FIGS. 11-12) to atransverse orientation following deployment in the vessel (bestillustrated in FIG. 13). In the illustrated embodiment as well asothers, the deflector 100 can be described as convertible between afolded configuration in which both the first end (e.g., lateral end 142)and the second end (e.g., lateral end 144) both point in the distaldirection, and a deployed configuration in which the first and secondends 142, 144 point in lateral directions.

Still referring to FIG. 6A, the first lobe 132 is symmetric to, andencloses a surface area that is the same or substantially the same as asurface area enclosed by the second lobe 134. In other embodiments, thefirst lobe 132 is asymmetric to, and can enclose a surface area that isat least 10%, 20%, 30%, 40%, 50%, 75%, 100% greater, or more than thesurface area enclosed by the second lobe 134. The lobular structure ofthe frame 106 allows the frame 106, in some embodiments, to havemultiple thicknesses along the perimeter of the frame to provide varyingstiffness as needed. The thinnest sections at each lateral end 142, 144of each lobe 132, 134 respectively, can have a thickness of from about0.30 mm to about 0.50 mm, or between about 0.38 mm and about 0.43 mm insome embodiments, can advantageously facilitate device collapse fordelivery without permanent deformation of the frame, which could be afactor for working in a sheath profile such as 6 French, or no greaterthan 10, 9, 8, 7, 6, 5, 4, or less French in some embodiments. In someembodiments, the frame 106 includes 3, 4, 5, 6, 7, 8, or more lobesprojecting radially outwardly from a central hub depending on thepatient's particular anatomy and luminal sites to be protected by thedeflector 100.

The deploy/collapse sequence emanates from the central struts 110, 120at the point of contact with the wall surrounding the distal opening ondeployment catheter 102 and continues to the radial ends of the lobes132, 134 of the frame 106 as the struts slide in or out of the catheter.One benefit of this design is that the physician can visualize therespective lateral ends 142, 144 of the lobes 132, 134 as they deployand radially expand, somewhat like a blooming flower. Another benefit isthat the deflector 100 typically does not reach straight across theaorta or touch the wall of the lesser curvature of the aorta whiledeploying.

Thus, one half of the axial length of the deflector along longitudinalaxis X1 may be greater than the diameter of the aorta in the vicinity ofthe ostium to the innominate artery, yet the deflector can be expandedor contracted within the aorta without contacting the wall on the insideradius of the thoracic aorta. This is because the lobes of the deflectoradvance radially outwardly as the shaft 300 is distally advancedrelative to the deployment catheter.

FIG. 6B is a close-up view of the respective lateral ends 142, 144 ofthe lobes 132, 134 highlighted in dashed circles 6B of FIG. 6A. Asdepicted in FIG. 6B, there are provided points of attachment 150 in theframe 106 for radiopaque (RO) markers 170 to be loaded. While themarkers 170 could be located anywhere along the deflector 100, in someembodiments, the frame 106 includes one, two or more markers 150 on orcentered about each lateral end 142, 144 as illustrated and one, two, ormore markers on the shaft (not shown) for alignment with a radiopaquemarker on the sheath. The radiopaque markers 170 on the frame lateralends 142, 144 and on the shaft as well as the visibility of the frame106 itself (if the frame 106 is at least somewhat radiopaque) aid inplacement guidance.

In some embodiments, the radiopaque marker elements 170 are made of ametal or a metal alloy, such as, for example, one or more of Nitinol,Elgiloy®, Phynox®, MP35N, stainless steel, nickel, titanium, gold,rhenium, tungsten, palladium, rhodium, tantalum, silver, ruthenium, andhafnium. The marker element could be a 90% platinum and 10% iridiumalloy in one particular embodiment. The radiopaque markers 170 disposedon the frame 106 or other portions of the deflector 100 may be welded,plated to the frame surface, painted thereon, dyed, applied as a wirewrap or coil, or any other suitable technique that allows for radiopaquemarking. The position of the markers 170, in some embodiments, may beoffset from the major axis of the frame to permit optimal folding of theframe 106.

FIG. 6C is a longitudinal cross-sectional view of the embolic deflectorof FIG. 6A, through line 6C-6C of FIG. 6A. As illustrated, thelongitudinal cross-section of the frame 106 of the deflector generallyfollows an arc 190 about its longitudinal axis. The arc 190 is definedas a best-fit curve having a constant radius of curvature, asillustrated in FIG. 6C. The actual device will not necessarily conformprecisely to a constant radius curve. In some embodiments, the radius ofcurvature of the best-fit curve 190 of the longitudinal cross-section ofthe deflector frame 106 is within the range of from about 0.5 inch toabout 6 inches, or from about 1 inch to about 3 inches.

FIG. 6D is a transverse cross-sectional view of the embolic deflector ofFIG. 6A, through line 6D-6D of FIG. 6A. Similar to that of thelongitudinal cross-section of the frame 106 discussed above, in someembodiments, the transverse cross-section of the membrane 108 (or frame106) can be approximated by a best-fit curve 191 having a constantradius of curvature, as illustrated in FIG. 6D. In some embodiments, theradius of curvature of the best-fit curve 190 of the longitudinalcross-section of the membrane 108 is generally within the range of fromabout 0.2 inches to about 2.0 inches, or from about 0.4 inches to about1 inch.

Thus, in some embodiments, a cross-section of the deflector can be saidto follow a best-fit curve about a first axis and a second axis, such asboth its transverse and longitudinal axes. In some embodiments, theradius of curvature of the best-fit curve 190 of the longitudinalcross-section of the frame 106 is at least about 100%, 150%, 200%, 400%,500%, or more of the radius of curvature of the best-fit curve 191 ofthe transverse cross-section of the membrane 108. In part due to itsgeometry as described maintaining a concave bias in a proximal directionwhen fully expanded, the deflector advantageously creates a seal along avessel well, such as the aortic arch, for positioning over the ostia ofthe brachiocephalic and the left common carotid arteries.

In other embodiments, the deflector can be said to follow a best-fitcurve about only one of its transverse and longitudinal axes. In someembodiments with a different configuration, a cross-section of the frameor membrane may not follow a best-fit curve along either axis.

In all of the foregoing illustrations, the deflector is illustrated asit would appear in an unconstrained expansion. In vivo, it is intendedthat the flexibility of the deflector be sufficient that it can conform(i.e. bend) to the interior wall of the native vessel, under relativelymild proximal traction on the shaft 300, without deforming theconfiguration of the native vessel. Thus, the periphery of the frame isconfigured such that along its entire length or at least about 90% ofthe length of the frame will lie in contact with the inner wall of thevessel. For this reason the ends 142 and 144 of the deflector reside onthe apexes of radiused axial ends of the deflector. The radiused endsare additionally curved in the device proximal direction as can be seenin FIGS. 5 and 6A through 6C, for example, to provide a generally boatshaped construct. This allow the deflector to reside within acylindrical structure and contact the inner wall of the cylinder alongsubstantially the entire length of the frame (the entire peripheral edgeof the deflector), thereby enclosing a trapped space beneath (on theproximal side of) the deflector.

The aspect ratio of the deflector may therefore be optimized to theintended anatomy in which the deflector is to be used. In oneimplementation of the invention, the length of the deflector isapproximately 2.3 inches and the width is approximately 0.82 inches. Theradius of curvature of the ends of the deflector is about 0.41 inches.Thus, the radius of curvature of the ends of the deflector isapproximately ½ the width of the deflector. In general, the radius ofcurvature of the ends of the deflector will be ½ of the width of thedeflector ±50%, preferably ±20%, in many embodiments ±10%, and, in oneparticular embodiment, ±2%.

In some embodiments, the frame 106 is configured for long-termimplantation and embolic protection. As such, the frame 106 may includea plurality of anchors, such as barbs that can be located anywhere alongthe length of the frame, such as at the lateral ends. The shaft in suchinstances can be detachable from the frame upon implantation. In someembodiments, it may be desirable for the deflector 100 to be eitherpartially or fully biodegradable over a period of time in which thepatient may be at a lesser risk for continued embolic formation, suchthat manual removal of the deflector 100 may advantageously not benecessary. As such, temporary embolic deflector devices could either beconfigured for manual removal as described elsewhere herein, orbiodegradable in other embodiments.

FIG. 7 illustrates one embodiment of a membrane 108 of the deflector100. The membrane 108 is configured to have a porous surface as to allowfor blood flow sufficient to perfuse the brain and other importantstructures served by the carotid and vertebral arteries, but alsodeflects emboli greater than a size of which is likely to cause anembolic stroke of clinical significance. In some embodiments, themembrane 108 has pores that are no more than about 200 μm, 175 μm, 150μm, 125 μm, 100 μm, 75 μm, 50 μm, or even less in size. In someembodiments, the membrane 108 has pores that are no more than about 100micrometers in size. The membrane 108 can be made of any of a variety ofbiocompatible materials, including, but not limited to polyurethane,PET, PETE, PETN, PTFE, polypropylene, polyacrylamide, silicone,polymethylmethacrolate, Gore-Tex®, or ePTFE with a high internodaldistance. The wall thickness of the membrane 108 can be about0.0001-0.005 inches, or about 0.0005-0.0015 inches in some embodiments.The wall thickness may vary depending on the particular materialselected. In some embodiments, the pores or other perfusion openings maybe laser-drilled out of the membrane material, or a heated rod or otherdevice could be used. The membrane 108 could be either elastic ornon-elastic. The membrane 108 may have either uniform or nonuniform poresizes and areal distributions and patterns. In some embodiments, themembrane 108 can be optionally filled or coated with a radiopaquematerial, and may be woven, extruded or otherwise film-formed, orairlaid.

In some embodiments, one, two, or more therapeutic agents are operablyattached to the membrane 108. The therapeutic agent could include ananticoagulant or clot-dissolving agent, such as, for example, heparin,hirudin, enoxaparin, fondaparinux, abciximab, epitibatide, tirofiban,aspirin, clopidogrel, warfarin, ticlopidine, tissue plasminogenactivator, or urokinase. The therapeutic agent could also include animmunosuppressant or antiproliferative agent, such as, e.g., paclitaxel,rapamycin, zotarolimus, prednisone, cyclosporine, methotrexate,mycophenolate, azathioprine, 6 MP, or tacrolimus. Other drugs orbioactive compounds could also be included depending on the desiredclinical result.

In some embodiments, the attachment of the membrane 108 to the frame 106is accomplished by overlapping the membrane 108 about the wire frame 106and heat bonding it to a backing membrane, and then trimming the bondededge, as described hereafter. Other options for attachment include usinga polymer, such as a polyurethane dispersion to coat the frame 106 andthen utilizing heat bonding, adhesive bonding, suturing, self-wrappingand bonding, mechanical bonding such as an interference fit by a doubleframe trapping the membrane material around the edges, stitching and/orultrasonic welding. In some embodiments, a dip process could be used toattach the membrane to the frame, similar to that of dipping a wand headinto soap for blowing bubbles.

One attachment method of the membrane 108 to the frame 106 is asfollows. First, the frame 106 is cleaned, such as with isopropanol, anddried completely, while the shaft 300 is similarly cleaned and dried.Dry nitrogen or another suitable agent can be used for the drying step.An attachment fixture may be used to facilitate rapid attachment. Thefixture should provide a positioning jig for membrane materials, and acompressible base, such as compression foam, on which the membrane 108and frame 106 may be positioned. A frame 106 that has been pre-assembledto a shaft 300 and fitted with sutures can then captured be in a yoke tohold the frame 106 flat. A backing membrane (not shown) is then placedon the attachment fixture. This backing membrane is preferably made fromthe same material as the porous membrane 108, and is provided with apre-cut aperture of a size and shape slightly smaller than the interiordimension of the frame 106 itself. The jig-captured frame 106 is thenpositioned on the fixture with the frame 106 overlaying the backingmembrane, and the porous membrane 108 is aligned atop the frame 106 inthe fixture. A compression plate/heater is placed over the fixture andclamped in place, and heat is applied for a short time to seal theporous membrane 108 to the backing membrane. After sealing, the edgesare trimmed smooth close to the frame. Finally, the shaft 300 is cleanedwith isopropanol and dried.

In some embodiments, the shaft 300 is an elongate, flexible solid orhollow wire that can be made of Nitinol or other materials, examples ofwhich are disclosed with respect to the frame 106 materials above. Theshaft 300 can be designed to have flexibility, column strength, andresist stretching under tension. The shaft 300 may also include a handleportion at its device proximal end for control by a physician or otheroperator.

The length of the shaft 300 will depend upon the intended vascularaccess point. In some embodiments, the shaft 300, or the entiredeflecting device including the shaft, is from about 100 cm to about 120cm, such as about 110 cm in length to allow for manipulation throughsheaths as long as 90 cm, or more. The shaft can have a low profileouter diameter, such as between about 0.030 inches and 0.040 inches, orabout 0.035 inches in some embodiments so that the physician can flushcontrast between the shaft and the sheath to confirm position of theshield.

FIG. 8 illustrates a cut-away view of one embodiment of the connection172 of the shaft 300 to the frame 106 of the deflector 100. The shaft300 is preferably provided with a distal (near connection to frame 106)end shape 320 that positively engages a complimentary portion of theframe attachment junction 130. The connection 172 can includecomplimentary male-female attachment structures, an interference fit,bonding or other adhesives, or other attachments. The connection 172 maybe secured with a hypotube 340 (sleeve or collar) that may also carry aradiopaque marker 170 of the shaft 300 as described above and mayprovide an attachment point for the retrieval sutures 42 describedelsewhere herein. Taper elements 341 which can be fillets of UV adhesivein some embodiments, provide a seal to the connection 172 andadvantageously provide a smooth transition at each end of the connection172.

One embodiment of a method of assembly of the shaft to the frame is asfollows. First, the shaft 300, sutures 42, frame 106, and hypotube 340are cleaned in isopropanol or other solvent and dried. An assemblyfixture for securing the components in the proper relationship to eachother and at the correct distances is preferably employed. The hypotube340 optionally containing the radiopaque marker 170 is positioned in thefixture, and the shaft 300 is inserted fully through the hypotube 340.The shaft 300 is then interlocked to the mating feature of the frame 106or otherwise attached, and the joint is drawn back into the hypotube 340and locked in position with the hypotube 340 covering the joint. Thesutures 42 (as described elsewhere herein are then looped around theframe 106 sides and the free ends inserted into the hypotube 340.Adhesive, such as Dymax 203-CTH-F-VLV is then wicked into the proximalend of the hypotube 340 in stages until it appears at the distal end, UVcured, and the process repeated until filling the hypotube 340. Thesuture 42 free ends are then trimmed flush with the proximal end of thehypotube 340. Finally, more adhesive is used to fill the proximal end ofthe hypotube 340 and is UV cured, creating a transition, such as aconical transition between the hypotube 340 and the shaft 300. Theassembly is then heat cured in an oven at about 245° F. forapproximately one hour.

Additional lumen may be provided, depending upon the desiredfunctionality of the embolic deflection system. For example, contrastdye or other flowable media may be introduced through a second lumen onthe deployment catheter, through a lumen extending through the shaft300, or by sizing the inside diameter of the main lumen of a singlelumen deployment catheter greater than the outside diameter of theguidewire or deflection device shaft to provide an elongate flow channelfrom the proximal manifold of the catheter to the distal opening. Inaddition or as an alternative to contrast dye, any of a variety ofthrombolytic agents or other drugs identified elsewhere herein such asin the discussion of the membrane may be infused. Normal saline,heparinized saline, or other rinse or flush media may also beintroduced, such as to clear any adherent debris from the membrane.Alternatively, a secondary lumen may be utilized to introduce any of avariety of additional structures, such as a pressure sensor to senseaortic blood pressure, or a cardiac output monitor to monitor blood flowor an emboli capture basket for positioning in the aorta downstream fromthe emboli deflector. Additional features may be added depending uponthe desired functionality of the embolic deflection system.

As depicted in FIGS. 5 and 8 above, and in greater detail in FIGS. 8A-8Cin other embodiments, one or more control lines 42 such as, for example,sutures can be used as an aid for retrieval of the deflector 100. A loopof suture 42 can be axially moveably trapped within a lumen formed bythe membrane 108 heat-bond and acts to lead the membrane 108 into thesheath 102 during retrieval. Sutures may be made of any appropriatematerial, such as nylon, catgut, PTFE, ePTFE, polyester, polyglycolicacid, poliglecaprone, polyethylene, polypropylene, or polyurethane,depending on the desired clinical result. Alternatively, the controlline 42 could be a single strand or multiple strand metal wire, orreplaced by any suitable retrieval aid such as an extension of themembrane 108 itself. In other embodiments, a control line 42 or otherretrieval aid is not required if the membrane attachment means does notrequire it for reliable retrieval.

Referring to FIGS. 8A to 8C, illustrated are various perspective viewsillustrating control lines 42 forming loops 43 around membrane 108 (notshown for clarity) operably connected to both transverse struts 110 andaround first 151 and second 153 sides of the frame 106. As shown,proximal retraction of the control lines 42 will cause the loops 43 tolead the membrane 108 and frame 106 into the sheath 102 and assist incollapsing the deflector 100 for removal.

In one embodiment, a plurality of sutures 42 are preformed into loopsthat attach to the frame 106 near the shaft 300 to aid in removal andrecapture of the deflector. These sutures can be suitably heat-formedinto a loop of appropriate shape and size to facilitate assembly withthe frame 106 and shaft 300 prior to attachment of the membrane 108 tothe frame 106. The sutures 42 are preformed by wrapping the suturematerial around a metal jig (that could be comprised of three closelyspaced metal pins arranged in a triangle) under tension and then heatingthe jig and suture material in an oven at about 350° F. for a sufficienttime to set the suture material (typically about 30 minutes) followed bycooling and removal from the jig.

As depicted in FIG. 5, the torque control 500, which functions similarto that of a wire pin vise, is used to stabilize the deflector 100 (notshown) during packaging, and also as a proximal handle to help grip andmanipulate the shaft 300 during use. Transmission of torque from theshaft 300 to the frame 106 can be particularly advantageous whilemanipulating the deflector 100 within the vasculature, in order torotate a radially asymmetric deflector 100 into its desired location,such as to cover the ostia of the brachiocephalic artery and the leftcommon carotid artery, for example. In some embodiments, the torquecontrol 500 can be used to grip guidewires up to 0.038″ in diameter andemploys a clamp 502 that can be rotated in an appropriate direction byan operator to reversibly lock and unlock onto the shaft 300.

The torque transmission capability of the shaft 300 will generallydecline as the shaft is made longer. Torque transmission capabilities ofthe shaft may be enhanced by constructing the shaft of non-polymericmaterial (e.g. solid metal wire or hypotube). Alternatively, shaft 300may be fabricated such as by wrapping a first polymeric filamenthelically around a mandrel in a first direction, and bonding a secondpolymeric filament wrapped helically in a second, opposing directionaround the first wrapping. Additional layers of helical wrapping orbraided constructions can provide relatively high torque transmission,as is understood, for example, in the intracranial microcatheter arts.

As illustrated in FIG. 10, the device can be loaded through a loadingtool, which can be operably connected to, in some embodiments, ablunt-tipped introducer sheath 604, that could be 6 French in size, thatcan allow the deflecting device to be flushed and back-loaded. Theintroducer 604 includes a silicone hemostasis valve (near 600) withintroducer shaft 602 connected to a flush port 610 (with stopcock) andlength of tubing 620, which can be optionally attached. The deflector100 is initially collapsed into the loading tool to evacuate all air.The deflector 100 then passes the hemostasis valve at the proximal end600 of the introducer sheath 604 and/or the delivery sheath 102.

In addition to the introducer 604 described above, FIG. 10 illustratesone, two, or more other components of a deflector system or kitincluding a deployment system 650 that can be packaged together in asterile fashion, and ready for physician use. The system also includethe deflector 100 as disclosed elsewhere herein, sheath 102 housing theshaft 300 (not shown) of the deflector 100, torque control 500 housing alength of guidewire 104, and other loading tools (not shown) asrequired.

The multi-lobed deflector 100 as illustrated in FIG. 5 can be placed andremoved as described above, such as in connection with FIGS. 3A-3E(upper extremity approach), FIGS. 4A-4F (femoral approach), directaortic puncture, or other approach as described above. An abbreviateddeployment sequence for the multi-lobed deflector will be illustratedand described in connection with FIGS. 11-13. As illustrated in FIG. 11,the deflector 100 can be positioned into the aortic arch by theSeldinger or other technique via the right radial, ulnar, brachial,axillary, or subclavian artery. As shown in FIG. 12, it is advanced tothe ostium of the brachiocephalic artery 16 where it is deployed in theaortic arch 12, in which the lobes 132, 134 of the deflector 100 areallowed to outwardly expand as shown in FIG. 8. The lateral ends of thedeflector 100 have atraumatic tips to prevent vessel damage in someembodiments. The two opposing radiopaque markers 170 on the lateral endsof the deflector frame (illustrated, e.g., in FIG. 6B) can be visualizedas one marker positioned toward the ascending aorta and the otherpositioned toward the descending aorta. As illustrated in FIG. 12A, theframe 106 is formed so that it is first biased into a proximally concaveshape when in an unconstrained expansion. However, after traction isapplied, following expansion of the deflector 100, traction can beapplied by the physician and the device is then pulled back intoposition to cover the ostia of both the brachiocephalic 16 and leftcommon carotid 24 arteries and traction is applied to maintain thedeflector 100 in position, as shown in FIG. 13. After application oftraction to form a fitting seal against the aortic wall when it isdeployed, the deflector 100 can in some embodiments invert from aconfiguration that is concave in the direction of the ostia of the leftcommon carotid artery as shown in FIG. 12A to a convex proximalconfiguration (in other words, concave towards a central axis of theaorta) as illustrated in FIG. 13. The shaft radiopaque marker and thesheath tip radiopaque marker can then be superimposed and visualized asone line. A slow flush of contrast may be used to confirm the seal overthese two vessels. FIG. 13A illustrates an alternative embodiment wherethe deflector 100 is sized and configured to cover the ostia of threeside branch vessels, including the brachiocephalic 16, left commoncarotid 24, and left subclavian 26 arteries. While the embodimentillustrated in FIG. 13A illustrate generally axially symmetric lobes132, 134 depending on the desired clinical result or patient anatomy thelobes may be alternatively axially asymmetric. For example, the maximumaxial length of a first lobe (e.g., 134) could be greater than, such as10%, 20%, 30%, 40%, 50%, 75%, or more greater than the maximum axiallength of a second lobe (e.g., 132). The deflector 100 can remain inplace throughout the emboli causing index procedure or other elapsedperiod of time and then can be removed as described above.

In some embodiments, the deflector 100 can be retrieved into the sheath102 by simply retracting the shaft 300 relative to the sheath 102. Thecentral struts fold together in the first action, then a second foldoccurs as the sheath forces the lateral ends of the lobes to be closedtogether. Once the deflector 100 is fully captured and changes into itscollapsed configuration inside of the sheath, the sheath and deflector100 can then be removed from the body. Variations on the procedure couldbe employed to minimize intimal damage and/or potential for release ofemboli during retrieval. The preferred procedural variation would be forthe user to advance the device and sheath tip into the aorta near thelesser curve of the arch, then re-sheath the device in that location.

FIGS. 14A-14K are top schematic views of various configurations ofalternative deflector frames, according to some embodiments of theinvention.

For example, in FIG. 14A, the deflector frame is radially symmetric anddome-shaped like an umbrella. The edge of the umbrella can be envisionedas a flexible, porous donut-shaped element, similar to the edge of adiaphragm, allowing a good seal with the curved aortic wall. A wire ringcan define the edge in some embodiments. The dome part of the umbrellacan include struts to assist in the opening and closing of the umbrellaand to help maintain its position. The center of the frame can have ahub on the inside surface to which the struts are attached. The deviceis pushed out of the delivery catheter with a tube, wire or other memberthat engages this hub. This hub assists with the opening of thedeflector. The hub remains attached to the deflector shaft, and theguide wire is used to pull the deflector into position. The deflectormay also self-expand if made, for example, of a shape memory material,resuming its shape after being released from its sheath. The deflectormay also include wires which assume their curved dome shape as they arereleased from the catheter. The porous membrane between the wires isattached, in some embodiments, at the highest point of the profile toassist with an umbrella-like deflection of clot or debris. The catheteritself may divide at its distal end to comprise the struts of thedeflector. A single wire may be shaped into petal-like struts for thedeflector which assume their umbrella shape upon exit from the deliverycatheter. The device may be provided with radiopaque markers or metalparts which are radiopaque as described elsewhere in the application.

Further embodiments of top views of deflector frames illustrated includeoval (FIG. 14B), rectangular (FIG. 14C), square (FIG. 14D), rectangularwith rounded lateral ends (FIG. 14E), cloud-shaped (FIG. 14F),starburst-shaped (FIG. 14G). FIGS. 14H-14K illustrate phantom plan viewsillustrating frames with 5 struts and a central hub (FIG. 14H), havingwide (FIG. 14I) and narrow (FIG. 14J) petals, or with concentricelements (FIG. 14K).

Other embodiments of the deflector frame have a rolled edge, or a flatporous edge. Another embodiment of the frame has no struts, but includesa nitinol or other biocompatible skeleton. Some embodiments include one,two, or more wires to position and anchor the device. Another embodimentof the device has anchors such as barbs, along the frame, e.g., at thelateral edges which help to maintain its position during the procedure.

Another embodiment of the deflector is parachute-like, with a ringgasket at its edge. The gasket would be held firmly in position over theostia of the appropriate vessels, such as the brachiocephalic and leftcommon carotid arteries. The billowy porous middle section would deflector trap embolic debris on its exterior surface while causing minimalresistance in the aorta. The middle portion would be inverted as it isremoved by pulling on wires attached to its center, capturing any clotstuck to it. Alternatively, the center of the device could be a screen,which fits more snugly against the aortic wall, with a very smallprofile, further preventing resistance. Again the device would beremoved by inversion, capturing any emboli or thrombus that mayaccumulate on the membrane or other component of the deflector prior toremoval.

Another embodiment of the deflecting device includes a rib-supported orself-supporting spherical frame covered by porous membrane, which may bedistorted into a flat or semi-flat shape for covering one, two, or morevessel ostia by withdrawing a wire attached to one side of the sphere.The device may be oval, rectangular or of another shape, some of whichare illustrated above, to assist in sealing of the edge against the wallof the aorta, covering the ostia of, for example, both thebrachiocephalic and left common carotid arteries and maintaining a lowprofile within the lumen of the aorta. The deflector of the presentinvention may take alternative shapes such as: round, oval, square,rectangular, elliptical, and edge-scalloped or irregular. This devicecould be modified in size in another embodiment in order to be used tocover the ostia of different vessels. The device may be coated with atherapeutic agent as described elsewhere herein.

Side view depth profiles of deflector frames are illustrated in FIGS.15A-15K. These depth profiles include onion-shaped (FIG. 15A),frustoconical (FIG. 15B), bi-level with multiple curvatures (FIG. 15C),bi-level concave-convex (FIG. 15D), flat (FIG. 15E), slightly rounded(FIG. 15F), oval (FIG. 15G), pyramidal (FIG. 15H), tent-shaped andpointed (FIG. 15I) or more rounded (FIG. 15J), tear-drop shaped (FIG.15K), or conical with a projection that may extend to the opposite wallof the aortic lumen, such as for improved anchoring (FIG. 15L). Thedeflector could include 1, 2, 3, or more frame and/or membrane layersand may be comprised of overlapping or connecting components.

FIGS. 16A-16D illustrate different embodiments of external lockingmechanisms that can assist in maintaining the deflector in a desiredposition in the body. FIG. 16A illustrates a clamp 700 that can fix theshaft 300 of the deflector 100 relative to the introducer sheath 604 ofthe deflector. FIG. 16B illustrates a threaded twist screw 702functioning similarly to that of the clamp 700 of FIG. 16A. FIGS. 16C-Dillustrates an expandable member configured to reside within theintroducer sheath 604 and at least partially surround the shaft 300 ofthe deflector 100 to prevent proximal or distal movement of the shaft300 within the introducer sheath 604. An inflatable balloon 704 isillustrated in FIG. 16C, that can be inflated or deflated, for example,via a separate inflation media lumen within the introducer sheath 604. Astent-like sleeve 706 is illustrated in FIG. 16D. In some embodiments,the sleeve 706 could have shape memory properties and radially expand orcontract with the application of heat or cold to the sleeve 706. In someembodiments, the locking mechanism can be incorporated with the torquecontrol as previously described.

FIGS. 17A-17D illustrate another embodiment of a deflector 100, wherethe frame 106 is an expandable wire structure having a first end 710 anda second end 712 that expands and flattens in an unstressedconfiguration once removed from a delivery sheath 102. FIG. 17Aillustrates in a perspective view the deflector frame 106 within thesheath 102, while a sectional view is illustrated in FIG. 17B. Partialexpansion of the frame 106 is illustrated in FIG. 17C, and completeexpansion is illustrated in FIG. 17D. Frame 106 is connected to membrane108 as described further above. In some embodiments, the straight-linedistance between the first end 710 and the second end 712 of the frame106 in its expanded configuration is at least about 20%, 30%, 40%, 50%,60%, 70%, 80%, or more shorter than the distance between the first end710 and the second end 712 of the frame in its collapsed configuration.

FIG. 18A-18C illustrate additional embodiments of frame 106 portions ofa deflector 100 that transform from a first collapsed configuration to asecond expanded configuration, wherein in which the second expandedconfiguration, the frame flattens into a disc, oval, or other shape asdescribed elsewhere in the application. Collapsed configurations of ahelical mesh frame 790 is illustrated in FIG. 18A; a spherical meshframe 792 in FIG. 18B, and an onion-shaped mesh frame 794 in FIG. 18C.

Although preferred embodiments of the disclosure have been described indetail, certain variations and modifications will be apparent to thoseskilled in the art, including embodiments that do not provide all thefeatures and benefits described herein. It will be understood by thoseskilled in the art that the present disclosure extends beyond thespecifically disclosed embodiments to other alternative or additionalembodiments and/or uses and obvious modifications and equivalentsthereof. In addition, while a number of variations have been shown anddescribed in varying detail, other modifications, which are within thescope of the present disclosure, will be readily apparent to those ofskill in the art based upon this disclosure. It is also contemplatedthat various combinations or subcombinations of the specific featuresand aspects of the embodiments may be made and still fall within thescope of the present disclosure. Accordingly, it should be understoodthat various features and aspects of the disclosed embodiments can becombined with or substituted for one another in order to form varyingmodes of the present disclosure. Thus, it is intended that the scope ofthe present disclosure herein disclosed should not be limited by theparticular disclosed embodiments described above.

What is claimed is:
 1. A method of reducing the risk of emboli enteringthe cerebral circulation as a consequence of an index procedure in theheart or the aorta, comprising the steps of: placing a wire through afirst side branch vessel and into the aortic arch; advancing anelongated introducer sheath over the wire and along the first sidebranch vessel until a distal end of the sheath is positioned in theaortic arch, wherein the elongated introducer sheath houses anexpandable emboli deflection device attached to a distal end of anelongate shaft, the emboli deflection device when expanded having aperiphery in plan view defined by a Nitinol skeleton, the peripheryhaving a concave depth profile with a concave side facing toward theshaft, the emboli deflection device having a porous material stretchedover the skeleton, the material having pores to allow the flow of bloodbut deflect or trap emboli; retracting the sheath to expose and permitthe emboli deflection device to expand, wherein the skeleton is sizedlarge enough to cover the ostia of each of the first side branch vesseland a second side branch vessel; manipulating the emboli deflectiondevice such that the concave side covers the ostia of each of the firstside branch vessel and the second side branch vessel, whereinmanipulating the deflection device comprises pulling the shaft to createa seal between the periphery of the emboli deflection device and a wallof the aortic arch around the ostia of the first and second side branchvessels; wherein the emboli deflection device permits blood flow fromthe main vessel into each of the first and second side branch vessels,but deflects emboli from entering the first and second side branchvessels; performing an index procedure in the heart selected from thegroup consisting of a balloon aortic or mitral valvuloplasty, a mitralor aortic valve replacement, and a coronary angioplasty; and retractingthe emboli deflection device into the sheath and withdrawing the sheathfrom the body.
 2. The method of claim 1 wherein the first branch vesselis the brachiocephalic artery.
 3. The method of claim 2, wherein thesecond side branch vessel is the left common carotid artery.
 4. Themethod of claim 1, wherein the index procedure is a transcatheter aorticvalve implantation.
 5. The method of claim 1, wherein the step ofretracting is done by inverting the emboli deflection device so that theconcave surfaces face away from the ostia of each of the first andsecond side branch vessels and then pulling the emboli deflectiondevices into the elongate shaft.
 6. The method of claim 5, wherein thedeflector includes drawstrings attached to the skeleton that enableinversion of the emboli deflection device.
 7. The method of claim 1,wherein the skeleton comprises first and second longitudinally extendinglobes extending in opposite directions along a long axis of theelongated periphery.
 8. The method of claim 7, wherein the embolideflection devices comprise first and second diverging struts extendingfrom a common junction connected to the distal end of the flexibleshaft.
 9. The method of claim 8, wherein each of the first and secondlaterally extending lobes has opposite medial ends which are eachconnected to one of the first and second struts.
 10. The method of claim9, wherein each of the first and second struts extend distally from thecommon junction and diverge from the other strut to define a mid-planeof the deflector with the first and second laterally extending lobesbeing symmetric.
 11. The method of claim 10, wherein each of the firstand second laterally extending lobes each formed of a thin curvednitinol member, and the first and second struts further laterallydiverge in opposite lateral directions and are contiguous with the thincurved nitinol members of the first and second laterally extendinglobes.
 12. The method of claim 10, wherein the first and secondlaterally extending lobes define an oval periphery having a minor axison the midplane and a major axis perpendicular thereto.
 13. The methodof claim 7, further including discrete radiopaque markers positioned atrounded ends of the first and second longitudinally extending lobes,wherein the step of manipulating includes viewing a position of theradiopaque markers.
 14. The method of claim 13, wherein the elongatedperiphery has a minor axis on the midplane and a major axisperpendicular thereto, and the discrete radiopaque markers arepositioned offset from the major axis to avoid interfering withretracting the emboli deflection device into the elongate shaft.
 15. Themethod of claim 1, further including means for preventing axial movementof the shaft within the sheath so as to maintain the emboli deflectiondevice in a desired position in the body.
 16. The method of claim 1,wherein the first side branch vessel is the brachiocephalic artery andthe second side branch vessel is the left common carotid artery, and theemboli deflection device has a sufficient length to cover and preventemboli from entering the ostia of the brachiocephalic artery, the leftcommon carotid artery, and the left subclavian artery.
 17. The method ofclaim 1, wherein an edge of the Nitinol skeleton is a flexible, porousdonut allowing a good seal with the curved aortic wall.
 18. The methodof claim 1, wherein an edge of the Nitinol skeleton is a rolled edgeallowing a good seal with the curved aortic wall.
 19. The method ofclaim 1, wherein an edge of the Nitinol skeleton is flat and porousallowing a good seal with the curved aortic wall.
 20. The method ofclaim 1, wherein the porous material is coated with heparin.